MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM THREADED GUIDE WIRE 150MM

Model Number	900.722
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent for a orif patella procedure.During the open reduction internal fixation of patella procedure, the surgeon bent a 1.25mm threaded guide wire while in the bone.When he backed it out using a mini driver the tip of the guide wire broke off leaving the threads inside the bone.A second guide wire was used but was inserted straight this time.After the surgeon over drilled with the 2.7 cannulated drill bit the guide wire came out with the drill bit but the threaded tip of the guide wire broke off and was left in the patient.After putting in the screw a third non-threaded guide wire was used to put in the last screw with no incident.There were fragments are generated and the surgeon left the broken tip of the guide wires in the patient.There was no surgical delay reported.The procedure was successfully completed.There were no patient consequences are reported.Concomitant devices reported: unknown mini driver (part# unknown; lot# unknown; quantity:1).2.7 cannulated drill bit (part# 310.67; lot# unknown; quantity:1).Unknown screw (part# unknown; lot# unknown; quantity:1).This complaint involves two (2) devices.This report is for (1) 1.25mm threaded guide wire 150mm.This report is 1 of 2 (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11678944
• Report Number: 2939274-2021-01892
• Device Sequence Number: 11538127
• Product Code: FZX
• UDI-Device Identifier: 10886982256331
• UDI-Public: (01)10886982256331
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900.722
• Device Catalogue Number: 900.722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.25MM THREADED GUIDE WIRE 150MM; 2.7MM CANNULATED DRILL BIT; UNK - SCREWS: TRAUMA; UNKNOWN MINI-DRIVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR